NCT03145441

Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation

The Impact of Pre-emptive Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There are several factors initiating cytokine storm and dysregulated systemic inflammatory response during cardiac transplantation. This may lead to serious perioperative complications: circulatory collapse, respiratory insufficiency, acute renal and liver failure, multi-organ dysfunction etc. On the other hand the high level of cytokines may play an important role in the development of graft rejection which is still a relevant problem in this patient group. There are some new data showing that the use of extracorporeal cytokine adsorber during long cardiopulmonary bypass time (\>120min) may be beneficial to prevent SIRS (Systemic Inflammatory Response Syndrome) with decreasing the level of cytokines in patients undergoing elective cardiac surgery. However there is lack of data and studies regarding the effect of extracorporeal cytokine adsorption during cardiac transplantation. The aim of the study is to investigate the effect of extracorporeal cytokine adsorber built in the cardiopulmonary bypass circle during heart transplantation. The hypothesis is that removal of cytokines during heart transplantation prevents the development of extreme systemic inflammatory response, hemodynamic collapse dominated by vasoplegia, and contribute to reduce the incidence of severe perioperative complications and early graft rejection.

Detailed description

Patients undergoing cardiac transplantation will be enrolled in the study after giving a written, signed informed consent. The participants will be randomized into two groups: * intervention group (30 patients): a cytokine adsorber (CytoSorb®) will be installed into the cardiopulmonary bypass circle during the operation * control group (30 patients): no cytokine adsorber will be used during cardiopulmonary bypass The investigators will collect demographic, clinical and laboratory data about patients before, during and after the operation. The the use of vasopressors and inotropes in the perioperative period, length of mechanical ventilation, ICU and hospital stay, and incidence of perioperative complications, early cellular or humoral graft rejection, and survival will be documented. The level of cytokines (IL-1, IL-6, IL-10, IL-17, tumor necrosis factor-alfa) and complements before, during and after the use of cardiopulmonary bypass will be determined if the investigators find relevant difference between the two groups in clinical variables.

Conditions

• Cardiac Transplantation
• Cardiopulmonary Bypass

Interventions

Type	Name	Description
DEVICE	CytoSorb®	CytoSorb® is a biocompatible, high adsorptive polymer indicated in conditions where cytokine levels are extremely elevated.

Timeline

• Start date: 2018-04-09
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2017-05-09
• Last updated: 2022-09-27

Locations

1 site across 1 country: Hungary

Regulatory

• FDA-regulated device study